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Impurity reference standards

Impurity Reference Standards
Impurity reference standards are physical benchmarks for implementing pharmaceutical quality standards. They serve as critical carriers for metrological traceability, acting as specialized tools to assess drug quality, establish measurement baselines, determine drug authenticity and efficacy, and calibrate testing instruments and methodologies. Within national drug standards, they are state-issued reference materials for both quantitative and qualitative analysis of pharmaceuticals.

Primary Functions

  1.Quality Control Applications:
  • Used as standard substances for drug identification, purity testing, and content determination.
  • Function as specialized "measuring tools" that directly impact the accuracy and reproducibility of test results.
  2.Targeted Impurity Control:

  • Essential for increasingly stringent impurity profiling, including localization, quantification, and response factor determination of specific impurities mandated by modern pharmacopeial standards.


Selection Criteria

  1.Source Availability:
  • Common Process-Related Impurities (e.g., by-products) are typically obtainable from pharmacopeial authorities (USP, EP) or certified suppliers (e.g., LGC).
  • Unique or Rare Impurities often require in-house synthesis, extraction, or isolation. Such impurities lack commercially available reference standards and necessitate method development, validation, and calibration to enable accurate quantification in active pharmaceutical ingredients (APIs).
  2.Critical Parameters for Procurement:
  • Purity: The cornerstone of reference standard quality (e.g., ≥98% by HPLC).
  • Shelf Life: Indicates stability under specified storage conditions.
  • Documentation: Complete Certificate of Analysis (COA) and spectral data (e.g., NMR, LC-MS).
  • Supplier Credentials: ISO/IEC 17034 accreditation, GMP compliance, and traceability to international standards.
Hengyuan Fine Chemical’s PCL Impurity Reference Standards
  Hengyuan Fine Chemical supplies PCL-branded impurity reference standards with the following advantages:
  • Full Documentation: Batch-specific COA and spectral data provided.
  • Direct Manufacturing Supply: Eliminates intermediaries, ensuring cost-effectiveness and rapid delivery.
  • Comprehensive Portfolio: Covers a wide range of pharmacopeial and custom-synthesized impurities.
  • Regulatory Readiness: Supports compliance with ICH, USP, and ChP requirements.
Contact us for technical specifications or procurement inquiries.

Product Number Image Product Name CAS No. Molecular Formula
Product Number:PCL-#-At102-100mg Atropine EP impurity D Product Name:Atropine EP impurity D CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Fl017-50mg Fmoc-His(Trt)-His(Trt)-OH Product Name:Fmoc-His(Trt)-His(Trt)-OH CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Tr122-50mg Trifluoperazine hydrochloride Product Name:Trifluoperazine hydrochloride CAS No.:440-17-5 Molecular Formula:
Product Number:PCL-#-El002-100mg Etiracetam Product Name:Etiracetam CAS No.:33996-58-6 Molecular Formula:
Product Number:PCL-#-To028-50mg Butyl 3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanoate (tofacitib impurity 26) Product Name:Butyl 3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanoate (tofacitib impurity 26) CAS No.:2227199-31-5 Molecular Formula:
Product Number:PCL-#-Ch073-25mg 1-(4-Chloro-phenyl)-3-dimethylamino-1-pyridin-2-yl-propan-1-ol (impurity O) Product Name:1-(4-Chloro-phenyl)-3-dimethylamino-1-pyridin-2-yl-propan-1-ol (impurity O) CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Bz0012-50mg Lipoic acid monooxide impurity 1 Product Name:Lipoic acid monooxide impurity 1 CAS No.:2114407-76-8 Molecular Formula:
Product Number:PCL-#-De064-25mg Ursodeoxycholic acid EP impurity E; 3α,12α-dihydroxy-5β-bilirubin-24-oleic acid (deoxycholic acid), deoxycholic acid Product Name:Ursodeoxycholic acid EP impurity E; 3α,12α-dihydroxy-5β-bilirubin-24-oleic acid (deoxycholic acid), deoxycholic acid CAS No.:83-44-3 Molecular Formula:
Product Number:PCL-#-Bz0085-50mg Sodium cholesterol sulfate impurity 1 Product Name:Sodium cholesterol sulfate impurity 1 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Cy104-1g o-Hydroxybenzonitrile Product Name:o-Hydroxybenzonitrile CAS No.:611-20-1 Molecular Formula:
Product Number:PCL-#-Zo008-50mg Zoledronic acid impurity A Product Name:Zoledronic acid impurity A CAS No.:1627731-60-5 Molecular Formula:
Product Number:PCL-#-Oi456-20mg Chinese Pharmacopoeia Impurity IV Product Name:Chinese Pharmacopoeia Impurity IV CAS No.:2362529-32-4 Molecular Formula:
Product Number:PCL-#-Bz0100-50mg Chlorpheniramine EP impurity E Product Name:Chlorpheniramine EP impurity E CAS No.:N/A Molecular Formula:
Product Number:PCL-#-P562-20mg 5-Chlorobenzo-2,1,3-thiadiazole Product Name:5-Chlorobenzo-2,1,3-thiadiazole CAS No.:2207-32-1 Molecular Formula:
Product Number:PCL-#-Bz0183-50mg 1,5,6,7-Tetrahydro-4H-pyrrolo[3,2-C]pyridin-4-one Product Name:1,5,6,7-Tetrahydro-4H-pyrrolo[3,2-C]pyridin-4-one CAS No.:736990-65-1 Molecular Formula:
Product Number:PCL-#-Bi2011-50mg 3,4-Bis(difluoromethoxy)benzaldehyde Product Name:3,4-Bis(difluoromethoxy)benzaldehyde CAS No.:127842-54-0 Molecular Formula:
Product Number:PCL-#-Di108-50mg (S,S)-2,8-Diazabicyclo[4,3,0]nonane (saxin side chain) Product Name:(S,S)-2,8-Diazabicyclo[4,3,0]nonane (saxin side chain) CAS No.:151213-42-2 Molecular Formula:
Product Number:PCL-#-Bz0075-50mg Atorvastatin impurity 10 Product Name:Atorvastatin impurity 10 CAS No.:1146977-93-6 Molecular Formula:
Product Number:PCL-#-Bz0022-50mg m-Hydroxylamine intermediate isomers Product Name:m-Hydroxylamine intermediate isomers CAS No.:639070-81-8 Molecular Formula:
Product Number:PCL-#-Am030-50mg Ambroxol hydrochloride impurity 4 Product Name:Ambroxol hydrochloride impurity 4 CAS No.:N/A Molecular Formula:
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